Natural Health Products Regulations

76 (1) The sponsor shall record, handle and store all information in respect of a clinical trial in a way that allows its complete and accurate reporting as well as its interpretation and verification.

(2) The sponsor shall maintain complete and accurate records to demonstrate that the clinical trial is conducted in accordance with good clinical practices and these Regulations.

(3) The sponsor shall maintain complete and accurate records in respect of the use of a natural health product in a clinical trial, including

• (a) a copy of all versions of the investigator’s brochure for the natural health product;

• (b) records respecting each change made to the investigator’s brochure, including the rationale for each change and documentation that supports each change;

• (c) records respecting all adverse events in respect of the natural health product that have occurred inside or outside Canada, including information that specifies the dosage form and the use and purpose of the natural health product at the time of the adverse event;

• (d) records respecting the enrolment of clinical trial subjects, including information sufficient to enable all clinical trial subjects to be identified and contacted in the event that the sale of the natural health product may endanger the health of the clinical trial subjects or other persons;

• (e) records respecting the shipment, receipt, disposition, return and destruction of the natural health product;

• (f) for each clinical trial site, an undertaking from the qualified investigator that is signed and dated by the qualified investigator prior to the commencement of his or her responsibilities in respect of the clinical trial, that states that

  • (i) the qualified investigator will conduct the clinical trial in accordance with good clinical practices, and

  • (ii) the qualified investigator will immediately, on discontinuance of the clinical trial by the sponsor, in its entirety or at a clinical trial site, notify both the clinical trial subjects and the research ethics board of the discontinuance, provide them with the reasons for the discontinuance and advise them in writing of any potential risks to the health of clinical trial subjects or other persons;

• (g) for each clinical trial site, a copy of the protocol, informed consent form and any amendment to the protocol or informed consent form that have been approved by the research ethics board for that clinical trial site;

• (h) for each clinical trial site, an attestation, signed and dated by the research ethics board for that clinical trial site, stating that it has reviewed and approved the protocol and informed consent form and that the board carries out its functions in a manner consistent with good clinical practices; and

• (i) for each clinical trial referred to in an application submitted under section 66 or subsection 71(3), the information referred to in subparagraph 66(c)(ix) and paragraph 66(f).

(4) The sponsor shall maintain all records referred to in this Part for a period of 15 years.